ITOVI SCANNER ITOVI TRACKER FCC ID: 2AGL3-TOV20021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for ITOVI SCANNER ITOVI TRACKER FCC ID: 2AGL3-TOV20021 manufactured by Itovi.

Event Text Entries

[113513879] Instructed by seller to complete this form, due to a massive recall, so they can exchange my device. I personally did not experience any problems with my itovi device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078284
MDR Report Key7670788
Date Received2018-07-06
Date of Report2018-07-05
Date Added to Maude2018-07-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameITOVI SCANNER
Generic NameDEVICE, GALVANIC SKIN RESPONSE MEASUREMENT
Product CodeGZO
Date Received2018-07-06
Model NumberITOVI TRACKER
Catalog NumberFCC ID: 2AGL3-TOV20021
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerITOVI


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-06

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